Short Course Radiation Therapy in Palliative Treatment of Brain Metastases
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
1 other identifier
interventional
108
1 country
1
Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2017
CompletedFirst Submitted
Initial submission to the registry
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedMay 18, 2018
May 1, 2018
5 years
May 3, 2018
May 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of palliation using the short course scheme compared with the standard scheme
Reduction of initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe)
3 months
Secondary Outcomes (3)
Acute toxicity in the two treatment groups
3 months
Late toxicity in the two treatment groups
12 months
Quality of Life (QoL) assessment in the two groups
12 months
Study Arms (2)
standard treatment
ACTIVE COMPARATORpatients in this group are treated with 3000 cGy in 10 daily fractions
short course treatment
EXPERIMENTALpatients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Interventions
1800 cGy in 4 fractions administered twice a day
Eligibility Criteria
You may qualify if:
- symptomatic brain metastases from solid tumors
- age \> 18 years
- ECOG performance status 0-3
- no changes in supportive care in the week before radiotherapy
You may not qualify if:
- pregnancy
- previous irradiation of the same region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, 40138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessio G Morganti, MD
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 15, 2018
Study Start
November 8, 2017
Primary Completion
November 8, 2022
Study Completion
November 8, 2023
Last Updated
May 18, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share